REINACH, Switzerland, April 17 /PRNewswire-FirstCall/ -- In order to give a comprehensive overview of the results of the two pivotal Phase III trials with intravenous iclaprim in complicated Skin and Skin Structure Infections (cSSSI), Arpida Ltd. today provides a table with the key data from the trials. Part of the data has already been published in previous press releases, while some additional statistical data are included that have not been announced before.
The efficacy data confirm the achievement of the pre-specified primary endpoint in the relevant populations in both trials. Moreover, pooling of the data from the two trials allows further powering and demonstrates that the pre-specified efficacy endpoint is achieved. Furthermore, the microbiological eradication rates for MRSA observed with iclaprim were very similar to those of the comparator. Finally, iclaprim showed a safety profile in the studies which was compatible with treatment of patients with cSSSI and compared favourably with the comparator.
Based on the Phase III results and on those of other studies carried out, Arpida is confident that intravenous iclaprim has compelling properties, both in terms of efficacy and safety. Arpida has filed a New Drug Application with the US FDA for intravenous iclaprim in cSSSI in March 2008.
The complete press release, including appendix, is available on http://www.arpida.com
About Arpida Ltd.
Arpida is a biopharmaceutical company with research facilities in Reinach, Switzerland and in the USA. It focuses on the discovery and development of novel drugs that seek to overcome the growing problem of microbial resistance. The most advanced compounds include an antibacterial under regulatory review and an antifungal in Phase III.
Arpida’s leading product candidate is intravenous iclaprim, a potent antibacterial that targets severe infections requiring hospital treatment, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). The clinical programme for the first indication, complicated skin and skin structure infections (cSSSI), has been completed. The submission of the NDA to the US FDA was completed in March 2008.
In December 2007, Arpida announced the enrolment of the first patients in a Phase II clinical study with intravenous iclaprim in the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP) or healthcare associated pneumonia (HCAP).
In January 2008, the US FDA granted authorisation to progress oral iclaprim into a Phase II ‘intravenous-to-oral’ switch trial. Iclaprim could be offered not only as an intravenous therapy for hospital use in acute situations, but also as an oral formulation, allowing early patient discharge followed by outpatient treatment. This switch could be a valuable instrument in reducing healthcare costs and enhancing patient comfort.
Arpida’s fourth most advanced antibiotic programme, AR-709, targets upper and lower respiratory tract infections acquired in the community setting. AR-709 exhibited potent activity against a large panel of pneumococcal clinical isolates including those resistant to currently used drugs. Promising results of “first-in-man” studies with AR-709 were published in March 2007.
An additional compound, AR-2474, has achieved in vivo proof of concept. AR-2474 has been shown to be effective in eradicating pathogens in preclinical models of skin infection and nasal carriage.
Apart from the antibiotic programmes, Arpida has an innovative antifungal therapy (TLT) which is in Phase III clinical trials in Europe, targeting onychomycosis.
Moreover, the company has several other leads in optimisation and additional discovery programmes derived from its own discovery platform at various research stages.
This press release contains specific forward-looking statements, e.g. statements including terms like believe, assume, expect or similar expressions. Such forward-looking statements are subject to known and unknown risks, uncertainties and other factors which may result in a substantial divergence between the actual results, financial situation, development or performance of the company and those explicitly or implicitly presumed in these statements. Against the background of these uncertainties readers should not place undue reliance on forward-looking statements. The company assumes no responsibility to update forward-looking statements or to adapt them to future events or developments.
CONTACT: Arpida contacts: Dr Khalid Islam, President and CEO, Tel:
+41-61-417-96-60; Harry Welten, MBA, CFO and Senior Vice President, Tel:
+41-61-417-96-65; Paul Verbraeken, Head of Corporate Communications, Tel:
+41-61-417-96-83.
